JP2013236948A - 膨張性ポリマーで構成される塞栓形成デバイス - Google Patents
膨張性ポリマーで構成される塞栓形成デバイス Download PDFInfo
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Abstract
【解決手段】動物内での移植のためのデバイスであって、該デバイスは、イオン化官能基を有するヒドロゲルを備え、該ヒドロゲルは、ポリ(エチレングリコール)ジアクリルアミド、ポリ(エチレングリコール)ジアクリレート、ポリ(エチレングリコール)ジメタクリレート、またはそれらの組み合わせ、の少なくとも1つのマクロマーを備え;そして当該少なくとも1つのマクロマーは約400グラム/モルから約35,000グラム/モルまでの分子量を有し、さらに、該ヒドロゲルは環境応答性であり、さらに、該ヒドロゲルは測定羽根に釣り合い重りを取り付けた試料剛性試験機を使用して測定した場合に約0.1mgから約85mgまでの非膨張時の曲げ抵抗を有する、前記デバイス。
【選択図】なし
Description
本出願は、米国仮特許出願第60/814,309号(2006年6月15日出願)の利益を主張する。
本発明は、血管動脈瘤の塞栓形成のような体腔の閉塞のためのデバイス、ならびに、かかるデバイスの作製方法および使用方法に関する。
結果は、第1世代ヒドロゲル1(HES)、第2世代マクロマー含有ヒドロゲル2、酸処理された第2世代マクロマー含有ヒドロゲル2、およびマイクロコイルの間の、相対的剛性の大きな差異を示している。ヒドロゲル1は白金マイクロコイル(大)の20倍近い剛性を有し、しかるに、ヒドロゲル2は白金マイクロコイル(大)の5倍未満の剛性を有する。酸処理されたヒドロゲル2は、白金マイクロコイル(大)よりも低い剛性を有し、白金マイクロコイル(小)とほぼ同程度の剛性を有する。当業者は、本発明で開示された方法および物質によって、はるかに柔軟性のある非膨張時クロマー含有ヒドロゲルが提供されることを認識する。医療デバイスにおいて使用されるときには、これらのヒドロゲルは、同様により柔軟性のある医療デバイスをもたらし得る。
Claims (41)
- 動物内での移植のためのデバイスであって、該デバイスは、イオン化官能基を有するヒドロゲルを備え、該ヒドロゲルは、ポリ(エチレングリコール)ジアクリルアミド、ポリ(エチレングリコール)ジアクリレート、ポリ(エチレングリコール)ジメタクリレート、またはそれらの組み合わせ、の少なくとも1つのマクロマーを備え;そして当該少なくとも1つのマクロマーは約400グラム/モルから約35,000グラム/モルまでの分子量を有し、さらに、該ヒドロゲルは環境応答性であり、さらに、該ヒドロゲルは測定羽根に釣り合い重りを取り付けた試料剛性試験機を使用して測定した場合に約0.1 mgから約85 mgまでの非膨張時の曲げ抵抗を有する、前記デバイス。
- 前記ヒドロゲルは、ポリエーテル、ポリウレタン、またはそれらの組み合わせを備える、請求項1に記載のデバイス。
- 前記イオン化官能基は、塩基性基を備える、請求項1に記載のデバイス。
- 前記塩基性基は、アミン、またはそれらの組み合わせを備える、請求項3に記載のデバイス。
- 前記塩基性官能基は、前記官能基のpKaを上回るpHで脱プロトン化され、または該官能基のpKa未満のpHでプロトン化され得る、請求項4に記載のデバイス。
- 前記イオン化官能基は、酸性基を備える、請求項1に記載のデバイス。
- 前記酸性基は、カルボン酸、またはそれらの組み合わせを備える、請求項6に記載のデバイス。
- 前記酸性官能基は、前記官能基のpKa未満のpHでプロトン化され、または該官能基のpKaを上回るpHで脱プロトン化され得る、請求項7に記載のデバイス。
- 前記ヒドロゲルは、ビニル、アクリレート、アクリルアミド、メタクリレート、またはそれらの組み合わせを備える、請求項1に記載のデバイス。
- 前記マクロマーは、ポリ(エチレングリコール)、またはそれらの組み合わせを備える、請求項1に記載のデバイス。
- 前記マクロマーは、ポリ(エチレングリコール)ジアクリルアミドを備える、請求項1に記載のデバイス。
- 前記ヒドロゲルは、実質的にアクリルアミドを含まない、請求項1に記載のデバイス。
- 前記マクロマーは、少なくとも1つのエチレン性不飽和化合物で架橋される、請求項1に記載のデバイス。
- 前記マクロマーは、N,N'-メチレンビスアクリルアミド、またはそれらの組み合わせで架橋される、請求項1に記載のデバイス。
- 前記ヒドロゲルは、N,N,N',N'-テトラメチルエチレンジアミン、過硫酸アンモニウム、アゾビスイソブチロニトリル、過酸化ベンゾイル、2,2'-アゾビス(2-メチルプロピオンアミジン)二塩酸塩、またはそれらの組み合わせから選択される、重合開始剤を使用して重合される、請求項1に記載のデバイス。
- 前記ヒドロゲルは、実質的に再吸収されない、請求項1に記載のデバイス。
- 動物内での移植のための環境応答性ヒドロゲルを調製するための方法であって、
a)ヒドロゲルを調製するために、少なくとも1つのエチレン性不飽和マクロマーであってポリ(エチレングリコール)ジアクリルアミド、ポリ(エチレングリコール)ジアクリレート、またはそれらの組み合わせを備え、約400グラム/モルから約35,000グラム/モルの分子量を有するもの、少なくとも1つのイオン化官能基を備える少なくとも1つのマクロマーまたはモノマー、少なくとも1つの重合開始剤、および少なくとも1つの溶媒を組み合わせるステップと、
b)生理的状態に応答する環境応答性ヒドロゲルを調製するために、該ヒドロゲルを処理するステップと、
を包含する、前記方法。 - 前記少なくとも1つのイオン化官能基は、酸性基を備える、請求項17に記載の方法。
- 前記処理するステップは、前記酸性基をプロトン化するために、前記ヒドロゲルを酸性環境で培養するステップを包含する、請求項18に記載の方法。
- 前記酸性基は、カルボン酸、またはそれらの組み合わせを備える、請求項18に記載の方法。
- 前記少なくとも1つのイオン化官能基は、塩基性基を備える、請求項17に記載の方法。
- 前記処理するステップは、前記塩基性基を脱プロトン化するために、前記ヒドロゲルを塩基性環境で培養するステップを包含する、請求項21に記載の方法。
- 前記塩基性基は、アミン、またはそれらの組み合わせを備える、請求項22に記載の方法。
- 前記溶媒は、水、エチルアルコール、またはそれらの組み合わせを備える、請求項17に記載の方法。
- 前記溶媒は水を備える、請求項24に記載の方法。
- 少なくとも1つのイオン化官能基を備える前記少なくとも1つのマクロマーまたはモノマーは、ビニル基、アクリレート、メタクリレート、アクリルアミド、またはそれらの組み合わせを備える、請求項17に記載の方法。
- 前記少なくとも1つのエチレン性不飽和マクロマーは、ポリ(エチレングリコール)、またはそれらの組み合わせを備える、請求項17に記載の方法。
- 前記少なくとも1つのエチレン性不飽和マクロマーは、ポリ(エチレングリコール)ジアクリルアミドを備える、請求項17に記載の方法。
- 前記エチレン性不飽和マクロマーは、約5重量%から約40重量%までの濃度である、請求項17に記載の方法。
- 前記溶媒は、約20重量%から約80重量%までの濃度である、請求項17に記載の方法。
- 前記組み合わせるステップは、複数のエチレン性不飽和部分を有する化合物を備える、少なくとも1つの架橋剤を加えるステップをさらに包含する、請求項17に記載の方法。
- 前記重合開始剤は、酸化還元重合開始剤を備える、請求項17に記載の方法。
- 前記重合開始剤は、N,N,N',N'-テトラメチルエチレンジアミン、過硫酸アンモニウム、アゾビスイソブチロニトリル、過酸化ベンゾイル、2,2'-アゾビス(2-メチルプロピオンアミジン)二塩酸塩、またはそれらの組み合わせを備える、請求項17に記載の方法。
- 前記組み合わせるステップは、ポロシゲンを加えるステップをさらに包含する、請求項17に記載の方法。
- 前記酸性基は、動物に移植後に、脱プロトン化が可能である、請求項19に記載の方法。
- 前記塩基性基は、動物に移植後に、プロトン化が可能である、請求項22に記載の方法。
- 前記エチレン性不飽和マクロマーは、ポリ(エチレングリコール)ジアクリルアミドを備え、少なくとも1つのイオン化官能基を備える前記少なくとも1つのマクロマーまたはモノマーは、アクリル酸ナトリウムを備え、前記少なくとも1つの重合開始剤は、過硫酸アンモニウムおよびN,N,N',N'テトラメチルエチレンジアミンを備え、前記溶媒は、水を備える、請求項17に記載の方法。
- 前記環境応答性ヒドロゲルは、実質的に再吸収されない、請求項17に記載の方法。
- 前記環境応答性ヒドロゲルは、実質的にアクリルアミドを含まない、請求項17に記載の方法。
- 前記少なくとも1つのエチレン性不飽和マクロマーは、非イオン性である、請求項17に記載の方法。
- 前記環境応答性ヒドロゲルは、測定羽根に釣り合い重りを取り付けた試料剛性試験機を使用して測定した場合に約0.1 mgから約85 mgまでの非膨張時の曲げ抵抗を有する、請求項17に記載の方法。
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